FDA & CDC Actions on “Updated Boosters”

The U.S. Food and Drug Administration (FDA) recently amended the emergency use authorizations (EUAs) of the Pfizer-BioNTech and Moderna COVID-19 Vaccines “to authorize bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination.”  The Bivalent vaccines, also called “updated boosters,” contain two messenger RNA components, “one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2.”  The FDA authorized the Pfizer-BioNTech Vaccine, Bivalent for individuals 12 years and older, and the Moderna COVID-19 Vaccine, Bivalent for individuals 18 years and older.  The U.S. Centers for Disease Control and Prevention (CDC) Director, Rochelle P. Walensky, MD, MPH, also recently “endorsed the CDC Advisory Committee on Immunization Practices’ recommendations for use of updated COVID-19 boosters from Pfizer-BioNTech for people ages 12 years and older and from Moderna for people ages 18 years and older.”  The updated boosters will help “to restore protection that has waned since previous vaccination by targeting variants that are more transmissible and immune-evading.”